NCT01670617Unknown不适用
A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 34
- 主要终点
- Improvement in KOOS scores
研究概览
简要总结
The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Improvement in KOOS scores
时间窗: Between baseline and 24 months post surgery
Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores
次要结局
- Incidence and time to reoperation/revision(5 years)
- Mean IKDC Knee Examination grades(Annually to 5 years post surgery)
- MRI Evaluation(Preop, 12 Months and 24 Months post surgery)
- Incidence of adverse events(Annually to 5 years post surgery)
- X-ray Evaluation(Preop, 12 months and 24 months post surgery)
研究者
研究点 (34)
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